BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM LUMINOS DRF

    MDR report key: 15724803 · Received November 4, 2022

    Report

    Report Number
    3004977335-2022-50610
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 27, 2022
    Report Date
    February 15, 2023
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K062623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS PRELIMINARY ANALYSIS: THE ISSUE IS NOT UNDERSTOOD YET. CURRENTLY IT IS ASSUMED THAT THERE MIGHT HAVE BEEN A PROBLEM WITH A POTENTIOMETER. FURTHER INFORMATION HAS BEEN REQUESTED FOR INVESTIGATION. INITIAL CORRECTIVE ACTIONS/PREVENTIVE ACTIONS IMPLEMENTED BY THE MANUFACTURER: WITH THE CURRENTLY AVAILABLE INFORMATION NO GENERAL PROBLEM HAS BEEN DETECTED FOR THE INSTALLED BASE WHICH REQUIRES AN IMMEDIATE ACTION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED BY SIEMENS. INTERNAL ID#(B)(4).

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION AND CLARIFICATION WERE OBTAINED DURING THE INVESTIGATION. H10 MANUFACTURER NARRATIVE: SIEMENS HEALTHCARE INVESTIGATED THE REPORTED ISSUE IN DETAIL. IT WAS STATED THAT ON (B)(6) 2022, THE SECOND PLANE TUBE STAND MOVED DOWNWARDS SPONTANEOUSLY WITHOUT USER COMMAND AFTER AN EXAMINATION WITH THE ORGAN PROGRAM (OGB) X AX ROTULE. THE TUBE TOUCHED THE PATIENT TABLE. THE PATIENT WAS HIT BUT NOT INJURED. IT WAS COMMUNICATED THAT THE TUBE MOVED DOWNWARDS AT A NORMAL SPEED. WHEN MOVING UPWARDS, THE BRAKING FORCE IN THE VERTICAL DIRECTION IS GREATER THAN OR EQUAL TO 75 NEWTON (7.6 KG) OVER THE ENTIRE RANGE AND GREATER THAN OR EQUAL TO 200 NEWTON (20.4 KG) IN THE WORKING RANGE FROM 600MM TO 1200MM. THE PROVIDED LOG FILES WERE ANALYZED AND RECREATED WITH SIMULATION SOFTWARE. AT THE COMMUNICATED TIMESTAMP, THE TUBE STAND WAS ABOVE THE WALL STAND AND NOT ABOVE THE BASIC UNIT TABLE AS DESCRIBED. THE MENTIONED ORGAN PROGRAM, X AX ROTULE, WAS NOT SELECTED AT THIS TIME. NO UNWANTED MOTOR MOVEMENT OF THE TUBELIFT AXIS COULD BE DETECTED IN THE FLCOMPACT.LOG FILES. EVERY MOVEMENT WAS TRIGGERED BY AN OPERATOR INPUT. IT CAN THEREFORE BE CONCLUDED THAT THE MENTIONED TIMESTAMP DOES NOT MATCH WITH THE DESCRIBED PROBLEM. TO FURTHER INVESTIGATE THE LOGS FOR THE DESCRIBED SYSTEM BEHAVIOR, LOG FILES FROM (B)(6) 2022 TO (B)(6) 2022, HAVE BEEN ANALYZED CONSIDERING THE USED ORGAN PROGRAM. ON (B)(6) 2022, SLIGHT ERRATIC CHANGES IN THE VALUES OF THE POSITION ENCODER FOR THE TUBELIFT AXLE COULD BE DETECTED. THESE CHANGES OCCURRED DURING THE MANUAL POSITIONING OF THE TUBE STAND FROM THE BUCKY WALL STAND (BWS) TO THE BASE UNIT. FOR THIS REPOSITIONING OF THE TUBE STAND, THE TWO BUTTONS HSLEFT BUTTON AND HSRIGHTBUTTON ON THE TUBE STAND CONTROL MODULE (TSCM) WERE PRESSED. THIS ENABLED ALL AXES OF THE TUBE STAND AS SPECIFIED. DURING MOVEMENT, THE ENCODER VALUE NORMALLY CHANGES LINEARLY UP OR DOWN. HOWEVER, IN THIS CASE, THREE (3) NON-LINEAR CHANGES CAN BE SEEN IN THE LOG FILES. THIS MAY INDICATE A MALFUNCTIONING ENCODER OF THE Z-AXIS, BUT NOT THE DESCRIBED MALFUNCTION OF THE TUBE STAND. AFTER THE TUBE STAND WAS POSITIONED FOR A KNEE EXAMINATION AT 16:12 (OGP "X AX ROTULE"), A SMALL UPWARD MOVEMENT IN THE POSITION OF THE TUBE LIFT AXIS CAN BE SEEN IN THE LOG FILES WHILE NO BUTTON WAS PRESSED. THE TUBE STAND MAY HAVE BEEN BUMPED BY THE PATIENT WHO SAT UP OR MOVED BY OPERATOR WITHOUT PRESSING ANY BUTTON. THE POSITIONS OF THE TUBE IN LONGITUDINAL (TUBE_LONG) AND TRANSVERSAL (TUBE_LATERAL) DIRECTION ALSO CHANGED AT THE SAME TIME. THESE VALUES CAN ONLY CHANGE WHEN BEING MOVED MANUALLY ON THIS SEMI-MOTORIZED TUBE STAND. BASED ON THE DATA ANALYSIS AND THE RESULTS WITH THE SIMULATION SOFTWARE, THE DESCRIBED BEHAVIOR OF THE TUBE STAND WAS NOT REPRODUCIBLE. THE DESCRIBED TUBE STAND MOVEMENT COULD NOT BE SEEN IN THE PROVIDED LOG FILES. ACCORDING TO THE LOCAL SERVICE ORGANIZATION IT WAS ALSO NOT POSSIBLE TO REPRODUCE THIS BEHAVIOR AT CUSTOMER SITE. THE MOTOR, INCLUDING THE ENCODER OF THE TUBE Z-AXIS, WAS REPLACED ON SITE. HOWEVER, THE DESCRIBED ERROR PATTERN DOES NOT INDICATE A DEFECT OF THE MOTOR. UNFORTUNATELY, THE PART WAS RETURNED UNDER WARRANTY INSTEAD OF AS COMPLAINT PART, SO THAT NO FURTHER INVESTIGATION WAS POSSIBLE. THE SPARE PART CONSUMPTION OF THE CONCERNED PART "MOTOR CPL" (MATERIAL NUMBER 7046787) SHOWS VALUES THAT ARE BELOW THE DEFINED THRESHOLD. BASED ON THE SPARE PART CONSUMPTION OF THE AFFECTED SYSTEM, THE MOTOR INCLUDING THE ENCODER WAS REPLACED ON (B)(6) 2022. IT CAN, THEREFORE, NOT BE EXCLUDED THAT AN INCORRECT TIME STAMP OF THE EVENT WAS COMMUNICATED. HOWEVER, THIS COULD NOT BE CONFIRMED BY THE SERVICE TECHNICIAN. THE LOG FILES FOR THIS DATE WERE NO LONGER AVAILABLE FOR EVALUATION. IN THIS CASE, THE MOST OBVIOUS CAUSE MAY BE A MALFUNCTION OF THE ALREADY REPLACED ENCODER OF THE TUBELIFT AXIS. ANY MOVEMENT CAN ONLY BE TRIGGERED BY PRESSING A BUTTON AND THE ASSOCIATED ACTIVATED DMG (DEAD MAN GRIP). WITHOUT PRESSING A BUTTON, NO MOVEMENT CAN BE PERFORMED. AN ENCODER DEVIATION (DELTA ERROR) WHEN A MOVEMENT IS REQUESTED (INCL. DMG) LEADS TO A SHORT MOVEMENT IN THE CASE OF SMALL DEVIATIONS AND TO A BLOCKAGE OF THE AXIS IN THE CASE OF A LARGER DEVIATION. IN GENERAL, EVERY MOTOR MOVEMENT CAN BE STOPPED AT ANY TIME BY PRESSING THE EMERGENCY STOP BUTTON. ACCORDING TO THE INFORMATION RECEIVED BY THE SERVICE TECHNICIAN, THE DESCRIBED PROBLEM DID NOT RECUR AFTER THE REPLACEMENT OF THE MOTOR INCLUDING THE ENCODER. THE SYSTEM IS FUNCTIONAL WITHOUT ANY FURTHER ISSUES. SINCE NO GENERAL PROBLEM WAS IDENTIFIED THE COMPLAINT IS CLOSED WITHOUT FURTHER MEASURES. H11 CORRECTED DATA: B3: THE DATE OF EVENT WAS (B)(6) 2022. THE DATE OF EVENT WAS ORIGINALLY REPORTED AS (B)(6) 2022 IN THE INITIAL REPORT SUBMITTED TO THE FDA ON 11/3/2022. D8: THE DEVICE WAS NOT SERVICED BY A THIRD PARTY AND SHOULD HAVE BEEN CHECKED "NO" IN THE INITIAL REPORT. H8: USAGE OF DEVICE WAS INCORRECTLY CHECKED AS "REUSE" IN THE INITIAL REPORT. THIS FIELD SHOULD HAVE BEEN BLANK.

    Description of Event or Problem · 0

    AFTER TAKING AN IMAGE USING THE AXIOM LUMINOS DRF SYSTEM, THERE WAS A SPONTANEOUS DOWNWARD MOVEMENT OF THE TUBE WITHOUT USER COMMAND. THE PATIENT WAS HIT BUT NOT INJURED. THE ISSUE COULD NOT BE REPRODUCED. EVEN THOUGH NO ONE WAS INJURED IN THIS CASE, IT IS ASSUMED THAT IN WORST-CASE SCENARIO A MINOR TO SERIOUS INJURY MIGHT BE THE OUTCOME SHOULD THE ISSUE RECUR. THE REPORTED EVENT OCCURRED IN BELGIUM.

    Description of Event or Problem · 0

    IT WAS STATED BY THE CUSTOMER THAT THE SECOND PLANE TUBE STAND MOVED DOWNWARDS SPONTANEOUSLY WITHOUT USER COMMAND AFTER AN EXAMINATION WITH THE ORGAN PROGRAM (OGB) X AX ROTULE. THE TUBE TOUCHED THE PATIENT TABLE. THE PATIENT WAS HIT BUT NOT INJURED. IT WAS COMMUNICATED THAT THE TUBE MOVED DOWNWARDS AT A NORMAL SPEED. WHEN MOVING UPWARDS, THE BRAKING FORCE IN THE VERTICAL DIRECTION IS GREATER THAN OR EQUAL TO 75 NEWTON (7.6 KG) OVER THE ENTIRE RANGE AND GREATER THAN OR EQUAL TO 200 NEWTON (20.4 KG) IN THE WORKING RANGE FROM 600MM TO 1200MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496430 AXIOM LUMINOS DRF INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10094200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown